Global Prospective Safety Analysis of Rivaroxaban

Study Questions:

What is the real-world safety profile of rivaroxaban when used for stroke prevention in atrial fibrillation (AF)?


The authors analyzed the XANTUS, XANAP, and XANTUS-EL prospective registries from 47 countries in North America, Europe, Middle East, Asia, and Latin America. These registries enrolled AF patients newly initiating rivaroxaban for stroke prevention and followed the patients for 1 year. The primary outcome was treatment-emergent major bleeding, adverse events, and all-cause death. Secondary outcomes included treatment-emergent thromboembolic events and nonmajor bleeding.


Across the three registries, 11,121 patients were included (mean age 70 ± 10.5 years, 42.9% female). Mean CHA2DS2-VASc score was 3.5. Major bleeding rates were 1.7/100 patient-years (95% confidence interval [CI], 1.5-2.0). All-cause death rates were 1.9/100 patient-years (95% CI, 1.6-2.2). Stroke and systemic embolism rates were 1.0/100 patient-years (95% CI, 0.8-1.2). One-year persistence of rivaroxaban therapy was 77.4% (lowest in East Asia [66.4%] and highest in Eastern Europe [84.4%]). Reasons for discontinuation included patient decision (7.1%), adverse event (6.5%), reason other than adverse event (3.4%), and patient now in sinus rhythm (1.6%). Use of dose-adjusted rivaroxaban (15 mg) varied from 14.8% to 44.4% across different regions.


The authors concluded that rivaroxaban therapy results in low bleeding and stroke rates when used for stroke prevention in AF. They also concluded that rivaroxaban-treated patients have high persistence of therapy at 1 year.


This important, practice-based, prospective registry analysis from 47 countries worldwide highlights the efficacy, safety, and high persistence with rivaroxaban therapy among AF patients. Event rates in this analysis compare favorably to the ROCKET AF clinical trial. However, the high degree of dose reduction deserves further investigation. Most promising is the high degree of medication persistence at 1 year, markedly higher than prior reports with warfarin.

Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Prevention, Anticoagulation Management and Atrial Fibrillation, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: Anticoagulants, Arrhythmias, Cardiac, Atrial Fibrillation, Embolism, Hemorrhage, Medication Adherence, Primary Prevention, Safety, Stroke, Thromboembolism, Vascular Diseases, Warfarin

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